HospitalInspections.org

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.21, QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM, was out of compliance.

A-0273 - Standard: Data Collection and Analysis - The facility failed to maintain a comprehensive quality program that showed measurable improvement in facility selected quality indicators, and demonstrated that the indicators resulted in improved health outcomes. Further, the facility failed to demonstrate the Governing Body specified the frequency and detail of data collection for its quality program. These failures resulted in incomplete quality processes and missed opportunities to improve patient safety and health outcomes.

A-0283- Standard: Quality Improvement Activities - The facility failed to take actions aimed at performance improvement, analyze if the implemented actions were successful, and track performance to ensure that improvements were sustained. The failure resulted in opportunities that affect health outcomes, patient safety, and quality of care were overlooked by the quality department, resulting in potential negative patient outcomes.

A-0286 - Standard: Patient Safety - The facility failed to ensure all adverse patient events were reported to the quality department in order to be analyzed and have corrective actions implemented. This failure resulted in a medication error being unknown to the quality committee and the Governing Body, resulting in potential negative patient outcomes.

A-0297- Standard: QAPI Performance Improvement Projects - The facility failed to maintain documentation of the quality department's improvement projects, the reasons for conducting the projects and the measurable progress achieved from each project. These failures resulted in incomplete quality processes and missed opportunities to improve patient safety and health outcomes.

A-308 - Standard: QAPI Governing Body - The facility's governing body failed to ensure the facility maintained and demonstrated evidence of an ongoing Quality Assessment and Performance Improvement (QAPI) program. The failure resulted in opportunities that affect health outcomes, patient safety, and quality of care being overlooked by the quality department, resulting in potential negative patient outcomes.

A-309 - Standard: Executive Responsibilities - The facility's Governing Body failed to ensure the facility possessed a comprehensive quality program that demonstrated selected quality indicator improvement actions were directed, approved, and evaluated. This failure resulted in the facility's ongoing Quality Assessment and Performance Improvement (QAPI) efforts not being directed, approved, or evaluated by the Governing Body.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.23, NURSING SERVICES, was out of compliance.

In addition, due to the nature of the survey findings, an Immediate Jeopardy was declared on 08/13/15 at 1:15 p.m. related to the Condition of Participation 482.23, NURSING SERVICES. The facility failed to provide oversight of nursing services by failing to ensure services were provided by nursing staff who had been trained and had their competencies evaluated in the administration and monitoring of high risk intravenous medications.

A-0386 - Standard: Organization - The Chief Clinical Officer (CCO) failed to provide oversight of nursing services within the facility by not ensuring nursing staff were adequately trained and received competency evaluations according to established policies and procedures. Further, the CCO failed to investigate and correct nursing process errors related to high alert and high risk IV medication administration in high observation areas. These failures resulted in high alert and high risk medications not being maintained and monitored correctly which potentially contributed to poor patient outcomes.

A-0397 - Standard: Patient Care Assignments - The facility failed to ensure patient staffing assignments were made based on patient's needs and the competence of nursing staff for 13 of 14 personnel records reviewed (Employees #1, #2, #4, #5, #6, #7, #9, #10, #12, #14, #15, #16 and #19).
This failure resulted in patients receiving high alert intravenous (IV) and high risk IV vasoactive medications from staff who were not trained and evaluated for competence in the administration of the medications.

A-0398 - Standard: Supervision of Contract Staff - The facility failed to ensure contracted personnel were properly oriented, competency evaluated, and adhered to the facility's policies and procedures for 2 of 2 non-employee (contracted) Registered Nurse (RN) personnel reviewed (RNs #1 and #23). This failure resulted in patients not being appropriately monitored while receiving high alert intravenous (IV) and high risk IV vasoactive medications.

A-0409 - Standard: Preparation and Administration of Drugs - The facility failed to ensure nursing personnel received special training and were competent to administer intravenous (IV) medications in accordance with hospital policies, procedures and protocols in 4 out of 4 medical records reviewed for patients requiring high alert and high risk intravenous (IV) medications (Patients #6, #10, #16 and #18). This failure resulted in inadequate patient monitoring and potentially contributed to negative patient outcomes.

Based on interviews and document reviews, the facility failed to maintain a comprehensive quality program that showed measurable improvement in facility selected quality indicators, and demonstrated that the indicators resulted in improved health outcomes. Further, the facility failed to demonstrate the Governing Body specified the frequency and detail of data collection for its quality program.

These failures resulted in incomplete quality processes and missed opportunities to improve patient safety and health outcomes.

Findings:

POLICY

According to the document, A Strategic Plan for Quality, the facility leadership team will align all improvement activities with the strategic AIMS for the organization. The facility leadership will build the infrastructure for regular review and alignment of new and on-going initiatives, through data collection, analysis, and reporting structures. Facility leadership will determine the scope and focus of measurement, set priorities for improvement, and systematically measure, analyze, and direct performance improvement.

According to the Strategic Quality Plan, the leadership of the facility, Quality Council, Medical Executive Committee, and Governing Board have the ultimate responsibility for monitoring and oversight of the effectiveness of the Quality Assessment and Performance Improvement (QAPI) process.

1. The facility's quality department did not ensure implementation of a quality program that demonstrated measurable improvement of its selected quality indicators used for quality activities and projects.

a) On 08/18/15 at 8:37 a.m., an interview with the Director of Quality Management (DQM) revealed the facility's quality department was conducting several quality projects, including Computerized Physician Order Entry (CPOE) documentation, and Change of Condition documentation. The DQM stated data for the CPOE and Change of Condition projects were collected through medical record audits and automatically through the documentation software used at the facility. The DQM stated that the collected data was discussed at relevant committee meetings. When the DQM was asked to provide documented evidence of the medical record audits , the DQM stated s/he did not have evidence of the medical record audits s/he completed in order to obtain the quality data.

b) On 08/18/15 at 8:37 a.m., and at 9:15 a.m., the DQM was asked to provide documentation regarding the facility's quality improvement projects. Specifically, the DQM was asked to provide documentation of why CPOE and Change of Condition documentation were selected as quality projects, when the governing body directed the frequency and detail of data collection, changes that were implemented, goals for the projects, how the facility measured if it met goals, evaluation of actions taken and quality project results, and how performance was tracked to ensure improvements were sustained by the facility.

No documentation was received prior to exiting the facility on 08/18/15 at 11:54 a.m.

c) During an interview on 08/18/15 at 8:38 a.m., the DQM stated quality indicator projects for the 2015 calendar year were:

Code Blue Reviews/Rapid Responses
Falls
Rate of Successful Ventilator Weans
Wean Protocol Utilization
Nosocomial Pressure Wounds
Blood Administration Infusion Times
Computerized Physician Order Entry
Patient Change of Condition Documentation
Critical Value Reporting Timeframes

Documentation of activities for each of these quality projects was requested on 08/18/15 at 8:38 a.m., and again at 9:15 a.m.

Specifically, the DQM was asked to provide documentation of why each quality improvement project was selected as a quality project, when the Governing Body directed the frequency and detail of data collection, changes that were implemented, goals for the projects, how the facility measured if it met goals, evaluation of actions taken and quality project results, and how performance was tracked to ensure improvements were sustained by the facility.

No documentation was received prior to exiting the facility on 08/18/15 at 11:54 a.m.

d) During an interview with the DQM on 08/18/15 at 10:35 a.m., s/he stated many of the quality improvement projects were not documented on paper, and that most of the information for the projects was discussed verbally during interdisciplinary rounds. This meant the reason for QAPI selection, goals, actions taken, and evaluation of projects all occurred verbally during interdisciplinary rounds.

The DQM explained the purpose of the facility "SQP/IDT Crosswalk Review Sheet" and "Performance Improvement Prioritization Grid" (Quality Sheets). The DQM stated these were corporate-wide quality forms that were completed during interdisciplinary rounds to identify quality projects from current inpatient issues. When asked to supply the Quality Sheets for the 2015 QAPI projects, the DQM stated s/he had not completed Quality Sheets for the any of the 2015 quality projects.

The DQM stated the forms were not used by the facility because there were no potential quality improvement projects discussed in interdisciplinary rounds that had not already been identified.

e) The DQM stated that in May and June, 2015, the facility was not meeting goals related to patient fall prevention. The DQM then stated the facility was not currently working on a project to reduce patient falls, and could not state if and when the facility would work to reduce patient falls. The DQM had previously identified "falls" as a quality improvement project for the facility, for 2015.

No documentation regarding patient falls was received prior to exiting the facility on 08/18/15 at 11:54 a.m.

Documentation of how quality improvement projects were selected, going back to January 1, 2015, was requested. The DQM stated s/he was not able to provide such documentation.

2. The governing body failed to provide guidance on the frequency and detail of quality indicator data collected by the quality program for its quality activities and projects.

a) The Director of Quality Management (DQM) was interviewed on 08/17/15 at 1:25 p.m., and on 08/18/15 at 8:37 a.m. During both interviews the DQM was asked to provide documented evidence of the Governing Body's involvement in specifications of data collection with quality activities and projects implemented by the quality department. The DQM supplied a copy of the Governing Board Report for meetings held on 12/05/14, 03/17/15, and 06/04/15.

b) Review of the Governing Board Report from meetings held on 12/05/14, 03/17/15, and 06/04/15 showed no evidence of discussion or approval of data collection frequency or details for quality indicators used in the quality program.

c) During an interview with the DQM on 08/18/15 at 9:15 a.m., s/he stated the facility had been working on CPOE as a quality project throughout 2015, but the Governing Board had not yet approved this QAPI project. The DQM stated the Governing Board would approve the CPOE project during their next Governing Board meeting to be held on 09/01/15.

During the same interview, the DQM stated the facility had been working on Change of Condition Documentation as a quality project throughout 2014 and 2015, but the Governing Board had not yet approved this QAPI project.

The DQM stated the Governing Board would approve the Change of Condition Documentation quality project during their next Governing Board meeting to be held on 09/01/15.

Based on interviews and document review, the facility failed to prioritize performance improvement projects, take actions aimed at performance improvement, analyze if the implemented actions were successful, and track performance to ensure that improvements were sustained.

This failure resulted in opportunities that affect health outcomes, patient safety, and quality of care were overlooked by the quality department, resulting in potential negative patient outcomes.

Findings:

POLICY

According to the document, A Strategic Plan for Quality, the facility leadership team will align all improvement activities with the strategic AIMS for the organization. The facility leadership will build the infrastructure for regular review and alignment of new and on-going initiatives, through data collection, analysis, and reporting structures. Facility leadership will determine the scope and focus of measurement, set priorities for improvement, and systematically measure, analyze, and direct performance improvement.

The Strategic plan gives priority to high volume, high risk, and problem prone areas.

The ultimate responsibility for performance improvement rests with the Hospital Governing Board. The Hospital Quality Council is the central coordinating body for all performance improvement and patient safety activities within the facility. The Quality Council set priorities for improvement, determines the scope and focus of measurement and systematically measures analyzes and directs performance improvement. The Quality Council maintains achieved improvements.

1. The facility failed to implement a prioritized comprehensive quality improvement program, based on high-risk problem prone-areas, that took actions aimed at performance improvement, analyzed if the actions were successful, and tracked performance to ensure that improvements were sustained.

a) During an interview on 08/18/15 at 8:38 a.m., the Director of Quality Management (DQM) stated Quality Assessment Performance Improvement (QAPI) projects for the 2015 calendar year were Computerized Physician Order Entry (CPOE) documentation, Change of Condition documentation and:

Code Blue Reviews/Rapid Responses
Falls
Rate of Successful Ventilator Weans
Wean Protocol Utilization, Nosocomial Pressure Wounds
Blood Administration Infusion Times
Computerized Physician Order Entry
Patient Change of Condition Documentation
Critical Value Reporting Timeframes

Documentation of each of these QAPI projects was requested on 08/18/15 at 8:38 a.m. and again at 9:15 a.m.

Specifically, the DQM was asked to provide documentation of why each quality project was selected as a quality project, if any of the selected projects were chosen because of high risk to patients, changes that were implemented, goals for the projects, how the facility measured if it met goals, evaluation of actions taken, and how performance was measured and tracked to ensure improvements were sustained by the facility.

b) During an interview with the DQM on 08/18/15 at 10:35 a.m., s/he stated many of the QAPI projects were not documented on paper, and that most of the information for the projects was discussed verbally during interdisciplinary rounds. This meant the reason for QAPI selection, goals, actions taken, and evaluation of projects all occurred verbally during interdisciplinary rounds.

The DQM stated s/he was not able to provide documentation of how quality improvement projects were chosen in the facility from 01/01/15 forward.

No documentation was received prior to exiting the facility on 08/18/15 at 11:54 a.m., indicating how the facility's quality program prioritized projects based on high-risk, problem-prone areas that affect patient safety and quality of care.

Additionally, no documentation was provided to show how the facility measured the success of the chosen quality improvement projects, tracked performance to understand if improvements were occurring, and ensured improvements were sustained.

Based on interviews and document reviews, the facility failed to ensure all errors related to patient care and safety were reported so that the quality committee could analyze errors and implement corrective actions.

This failure resulted in medication errors being unknown to the quality department, resulting in potential negative patient outcomes.

Findings:

POLICY

According to the document, A Strategic Plan for Quality, AIM Two is to provide care, which is safe and reliable and meets regulatory standards. Delivery of patient care will be provided in a manner that minimizes the risk of harm to patients. Leadership must be "present at work" and identify safety issues, concerns, and errors and instruct staff on ways to improve.

1. The facility's quality committee and Governing Body failed to ensure all medication errors were obtained in order to ensure errors which affected patient care and safety were tracked and analyzed.

a) Medical record review of Patient #1 revealed a physician order for Diazepam, 10 milligrams (mg) every six hours beginning on 07/25/15 at 9:25 p.m.

Medication Administration documentation for Patient #1 revealed on 08/03/15, Registered Nurse (RN) #13 administered 10 mg of Diazepam at 9:31 a.m. Subsequently, RN #2 administered 10 mg of Diazepam at 12:02 p.m., approximately 3 hours and 30 minutes before the next dose should have been given. A Change of Condition documentation note, authored by RN #2 on 08/30/15 at 12:28 p.m., stated the medication was administered sooner than 6 hours, at 12:50 p.m., the manual blood pressure for the patient was 80/50, and an order was received for 500 ml bolus of normal saline.

b) Review of facility incident reports revealed no documentation about the medication error exhibited in the medical record review of Patient #1 regarding the administration of Diazepam more frequently than every 6 hours, as order by the patient's physician.

c) On 08/17/15 at 3:45 p.m., the Director of Quality Management (DQM) confirmed the incident reports supplied included all medication errors from the facility. The DQM stated s/he was not aware of the medication error involving Patient #1 but would have expected to be notified of the error through the facility's incident reporting process.

d) During an interview on 8/12/15 at 2:33 p.m., the Chief Clinical Officer (CCO) stated the facility had not started "tracking and trending" medication variances and errors. The CCO stated no remediation training had been completed yet for any nursing staff.

Based on interviews and document reviews, the facility failed to maintain documentation of the quality department's improvement projects, the reasons for conducting the projects, and the measurable progress achieved from conducting each project.

These failures resulted in incomplete quality processes and missed opportunities to improve patient safety and health outcomes.

Findings:

POLICY

According to Strategic Quality Plan, the leadership of the facility, Quality Council, Medical Executive Committee, and Governing Board have the ultimate responsibility for monitoring and oversight of the effectiveness of the QAPI process.

The facility leadership will build the infrastructure for regular review and alignment of new and on-going initiatives, through data collection, analysis, and reporting structures. Facility leadership will determine the scope and focus of measurement, set priorities for improvement, and systematically measure, analyze, and direct performance improvement.

Leaders will effectively identify issues, allocate resources and lead deployment operational processes to maintain quality or to accomplish needed change.

The ultimate responsibility for performance improvement rests with the Hospital Governing Board. The Hospital Quality Council is the central coordinating body for all performance improvement and patient safety activities within the facility. The Quality Council set priorities for improvement, determines the scope and focus of measurement and systematically measures analyzes and directs performance improvement.

1. The facility failed to maintain and demonstrate documented evidence of each quality assessment performance improvement (QAPI) project being conducted, the reasons for conducting the projects, and measurable progress achieved on each project.

a) During an interview on 08/18/15 at 8:38 a.m., the Director of Quality Management (DQM) stated quality indicator projects for the 2015 calendar year were:

Code Blue Reviews/Rapid Responses
Falls
Rate of Successful Ventilator Weans
Wean Protocol Utilization
Nosocomial Pressure Wounds
Blood Administration Infusion Times
Computerized Physician Order Entry
Patient Change of Condition Documentation
Critical Value Reporting Timeframes

Documentation of each of these quality projects was requested on 08/18/15 at 8:38 a.m. and again at 9:15 a.m.

Specifically, the DQM was asked to provide documentation of why each quality project was selected as a quality project, changes that were implemented, goals for the projects, how the facility measured if it met goals, evaluation of actions taken, and how performance was tracked to ensure improvements were sustained by the facility.

During an interview with the DQM on 08/18/15 at 10:35 a.m., the DQM stated many of the QAPI projects were not documented on paper, and that most of the information for the projects was discussed verbally during interdisciplinary rounds. This meant the reason for QAPI selection, goals, actions taken, and evaluation of projects all occurred verbally during interdisciplinary rounds.

The DQM stated there were "Quality Sheets" in the facility that were to be completed during interdisciplinary rounds to identify quality projects from current inpatient issues. When asked to supply the Quality Sheets for the 2015 QAPI projects, the DQM stated s/he had no Quality Sheets to support any of the 2015 quality projects.

Documentation of how quality projects were selected going back to January 1, 2015 was requested. The DQM stated s/he was not able to provide this documentation.

No additional documentation was received prior to exiting the facility on 08/18/15 at 11:54 a.m.

b) Documentation of the "Falls" QAPI project was requested on 8/18/15 at 8:38 a.m., from the DQM.

In an interview with the DQM at the same time, s/he stated that in May and June, 2015, the facility was not meeting goals related to patient fall prevention. When asked what the goal was or if any actions were implemented to decrease patients' falls, the DQM stated the facility was not currently working on this quality improvement project even though s/he listed "Falls" as a quality improvement project for 2015.

The DQM could not provide documentation showing that a quality improvement project to reduce patient falls was needed in the facility or was not needed due to improved outcomes.

Based on interviews and document reviews, the facility's governing body failed to ensure the facility maintained and demonstrated evidence of an ongoing quality assessment and performance improvement (QAPI) program.

The failure resulted in opportunities that affect health outcomes, patient safety, and quality of care were overlooked by the quality department, resulting in potential negative patient outcomes.

Findings:

POLICY

The ultimate responsibility for performance improvement rests with the Hospital Governing Board. The Hospital Quality Council is the central coordinating body for all performance improvement and patient safety activities within the facility. The Quality Council sets priorities for improvement, determines the scope and focus of measurement, and systematically measures, analyzes, and directs performance improvement.

The Strategic plan gives priority to high volume, high risk, and problem prone areas.

All performance improvement activities are reviewed in the appropriate Quality Council Committee prior to review at Quality Council meetings.

1. The facility's governing body failed to ensure the facility involved all departments and services in the QAPI program and maintained and demonstrated evidence of an ongoing Quality Assessment and Performance Improvement (QAPI) program.

a) The Director of Quality Management (DQM) was interviewed on 08/17/15 at 1:25 p.m. and on 08/18/15 at 8:37 a.m. The DQM provided a copy of the Governing Board Report for meetings held on 12/05/14, 03/17/15 and 06/04/15. Review of the Governing Board Report from these meetings showed no evidence of discussion or approval of data collection frequency or details for quality indicators used in the quality program, nor did they show improvement actions were evaluated.

On 08/18/15 at 8:37 a.m. an interview was conducted with the DQM who stated a current quality improvement project, Computerized Physician Order Entry (CPOE) contained data that was collected automatically through the documentation software used at the facility from patient medical records. The DQM could provide no evidence of the medical record audits s/he completed to obtain the quality data.

b) During an interview with the DQM on 08/18/15 at 9:15 a.m., s/he named 3 quality improvement projects the facility had been conducting during 2015. The projects were Computerized Physician Order Entry (CPOE), Blood Administration Infusion Times, and Change of Condition Documentation (throughout 2014 and 2015). The DQM stated the Governing Board had not yet approved these quality indicators as QAPI projects. S/he could not state why the programs were identified as needed quality improvement programs and could provide not documentation.

The DQM stated the Governing Board approved QAPI projects retroactively, which meant the Governing Board would review and approve QAPI projects completed during the previous calendar year. S/he stated the CPOE QAPI project would be approved during the facility's next Governing Board meeting to be held on 09/01/15.

c) During an interview on 08/18/15 at 8:38 a.m., the DQM stated quality indicator projects for the 2015 calendar year were:

Code Blue Reviews/Rapid Responses
Falls
Rate of Successful Ventilator Weans
Wean Protocol Utilization
Nosocomial Pressure Wounds
Blood Administration Infusion Times
Computerized Physician Order Entry
Patient Change of Condition Documentation
Critical Value Reporting Timeframes

Documentation of each of these quality projects was requested on 08/18/15 at 8:38 a.m. and again at 9:15 a.m. The DQM could provide no documentation of these quality projects prior to exiting the facility on 08/18/15 at 11:54 a.m.

d) During an interview with the DQM on 08/18/15 at 10:35 a.m., the DQM stated many of the QAPI projects were not documented on paper, and that most of the information for the projects was discussed verbally during interdisciplinary rounds. This meant the reason for QAPI selection, goals, actions taken, and evaluation of projects all occurred verbally during interdisciplinary rounds and were not documented.

Based on interviews and document reviews, the facility's Governing Body failed to ensure the facility implemented and maintained a comprehensive quality program that demonstrated quality improvement projects were prioritized, a distinct number of these projects were chosen each year, and all improvement activities were evaluated by the responsible parties.

These failures resulted in the facility's ongoing quality assessment and performance improvement (QAPI) efforts not being directed, approved, or evaluated by the Governing Body.

Findings:

POLICY

According to the Strategic Quality Plan, the leadership of the facility, Quality Council, Medical Executive Committee, and Governing Board have the ultimate responsibility for monitoring and oversight of the effectiveness of the QAPI process.

The ultimate responsibility for performance improvement rests with the Hospital Governing Board. The Hospital Quality Council is the central coordinating body for all performance improvement and patient safety activities within the facility. The Quality Council set priorities for improvement , determines the scope and focus of measurement and systematically measures analyzes and directs performance improvement. The Quality Council maintains achieved improvements.

The facility leadership team will align all improvement activities with the strategic AIMS for the organization. The facility leadership will build the infrastructure for regular review and alignment of new and on-going initiatives, through data collection, analysis, and reporting structures. Facility leadership will determine the scope and focus of measurement, set priorities for improvement, and systematically measure, analyze, and direct performance improvement.

It is necessary to have a defined, criteria based process in place for prioritization of projects and the ability to adjust priorities in response to unusual or urgent events. The Strategic plan gives priority to high volume, high risk, and problem prone areas.

Leaders set the direction and align and coordinate strategic priorities, key initiatives, and improvement activities. Leaders will effectively identify issues, allocate resources and lead deployment operational processes to maintain quality or to accomplish needed change.

Leadership will build the infrastructure for regular review and alignment of new and on-going initiatives through data collection, analysis and reporting structures.

1. The facility's Governing Board failed to determine the number of distinct quality projects to be conducted annually, failed to prioritize the quality improvements projects, and failed to ensure that all improvement actions were evaluated.

a) The Director of Quality Management (DQM) was interviewed on 08/17/15 at 1:25 p.m. and on 08/18/15 at 8:37 a.m. The DQM supplied a copy of the Governing Board Report for meetings held on 12/05/14, 03/17/15 and 06/04/15. The meeting minutes showed no evidence of discussion or approval of current quality improvement projects or that the projects were being evaluated.

The DQM stated the Governing Board approved QAPI projects retroactively, which meant the Governing Board would review and approved QAPI projects completed during the previous calendar year. The DQM could provide no documention that the Governing Board chose and approved the quality improvement projects which s/he stated were being conducted in 2015. According to the DQM the projects included:

Computerized Physician Order Entry (CPOE)
Change of Condition Documentation
Code Blue Reviews/Rapid Responses
Falls
Rate of Successful Ventilator Weans
Wean Protocol Utilization
Nosocomial Pressure Wounds
Blood Administration Infusion Times
Computerized Physician Order Entry
Patient Change of Condition Documentation
Critical Value Reporting Timeframes

There was no documentation to show the Governing Board ensured an ongoing hospital-wide QAPI program for quality improvement and patient safety was implemented and maintained.

Based on interviews and document reviews, the Chief Clinical Officer (CCO) failed to provide oversight of nursing services within the facility by not ensuring nursing staff were adequately trained and received competency evaluations according to established policies and procedures. Further, the CCO failed to investigate and correct nursing process errors related to high alert and high risk IV medication administration in high observation areas.

These failures resulted in high alert and high risk medications not being maintained and monitored correctly which potentially contributed to poor patient outcomes.

Findings:

1. The Chief Clinical Officer (CCO #19), failed to ensure nursing services were provided in a safe and effective manner by trained, competent and qualified staff.

a) During an interview, on 8/12/15 at 2:33 p.m., the CCO was asked what training and competency tools preceptors used to ensure Registered Nurses (facility staff and contracted agency staff) were uniformly trained and consistently evaluated for competency prior to providing services independently in the High Observation Unit (Medical Observation Unit, MOU). The CCO stated s/he would have to defer to the Education Coordinator as s/he was not of aware of the training process.

The CCO stated s/he had not provided any guidance to RN preceptors on methods or tools which should be used to train and evaluate the competency of nursing staff caring for patients in the MOU. CCO #19 stated it was a "fair statement" that there was currently no oversight or standard process to ensure RNs were consistently evaluated to ensure safe and effective patient care.

Additionally, the CCO stated there was quite a bit of turnover and there was currently "not a lot of stability."

The CCO stated when agency RNs were new to the facility, they were observed to see what their skill level was. CCO #19 stated the contracted agency had all the competency files, and the facility didn't have any competency evaluations for agency RNs. S/he stated agency RNs received training with a preceptor, but s/he wasn't sure how many shifts that entailed, as well as, the exact training provided and if any specific competency skills were evaluated. The CCO stated it would be at the discretion of the nursing supervisor as to how long a contracted nurse would receive training. S/he wasn't sure if nursing supervisors were aware of how much training was required for contracted agency RN orientation and competency evaluation.

The CCO stated if a nurse didn't have the skill set to work in the MOU, s/he would not be assigned to work in the MOU. S/he wasn't sure who decided when a nurse was deemed competent to administer and monitor high alert and high risk medications. The CCO stated the nursing supervisors would most likely make that decision as they worked more closely with nursing staff than s/he did. However, the CCO acknowledged s/he was currently acting as the nursing supervisor for the facility and all nursing staff were ultimately accountable to him/her.

Further, CCO #19 acknowledged s/he was not aware how facility RNs and contracted agency RNs were trained on the facility's IV Heparin and high risk vasoactive IV administration policies and procedures.

When asked about the conflicting information between the facility's IV Heparin policy and the IV Heparin protocol regarding Partial Thromboplastin Time (PTT) collection timeframes, the CCO stated s/he was not aware they were different, and the facility had a lot of opportunity to improve.

b) On 08/14/15 at 11:55 a.m., an interview with the Education Coordinator (Employee #20) revealed the facility's required "High Observation" competency process was not being followed by him/her and the CCO. S/he clarified the term "High Observation" referred to a level of care where patients, or their medications, required more frequent monitoring than a Medical Surgical Unit could provide. This included patients who received hemodynamic and vasoactive IV medications or were receiving services in the Medical Observation Unit (MOU).

According to the policy, Criteria for Medical Observation Unit, Examples of High Risk Med Infusions included (in part) Dopamine and Levophed. All nurses administering the above medications must have certification in advanced cardiac life support (ACLS) and have successfully completed the appropriate MOU (Medical Observation Unit) nursing competencies: i.e. telemetry, dopamine administration, including the RN Critical Care/High Observation unit competencies.

c) Review of nursing staff training files for 13 of 14 RNs assigned to care for high observation patients in the MOU revealed they had not completed the RN Critical Care/High Observation Unit Competencies, despite having administered high alert and high risk IV medications.

There was no evidence RNs #1, #2, #4, #6, #7, #9, #10, #11, #13, #14, #15, #16 and #23 had been trained and deemed competent to provide care, including specialized services, to patients in the facility's MOU or high observation unit.

Record review showed all 13 Registered Nurses who had not received a competency evaluation for the facility's High Observation Unit (MOU) provided care for patients in the MOU.

d) Additionally, facility RNs provided training and orientation for contracted agency staff to work in the MOU despite not having completed the required training and having his/her own skills evaluated to ensure services were provided in a safe and effective manner.

On 08/13/15 at 12:09 p.m. an interview with RN #2 revealed s/he had not received any training or guidance on how to train new nursing staff, despite having trained several new nurses, including contracted agency nurses. S/he stated RNs at the facility were asked to use their own nursing judgment when training nurses, and weren't offered any specific guidance as to what qualified new nursing staff as "competent."

RN #2 stated s/he trained a new contracted agency RN, and the focus of the training was on how to document, how to use the facility's computer charting software, how to contact physicians if needed, and how to look up which physician to call.

e) On 08/12/15 at 11:23 a.m., an interview with RN #1 revealed s/he had 1 year of rehabilitation nursing experience and was on his/her first assignment in an acute care setting. RN #1 stated she did not receive training or a competency evaluation for administration and maintenance of IV Heparin, IV Dopamine, or IV Epinephrine, nor had s/he administered those medications previously in another environment.

RN #1 stated s/he asked several times for a protocol sheet and never received one. S/he did not receive a sheet with heparin protocol while in training. RN #1 stated sometimes s/he didn't feel the support was adequate; s/he would ask for a policy on something and the facility would say they didn't have a policy.

f) During an interview on 8/12/15 at 2:33 p.m., the CCO stated the facility had not started "tracking and trending" medication variances and errors related to administration and monitoring of high risk and high alert IV medications. The CCO stated no remediation training had been completed yet for any nursing staff. The CCO stated RN training was not revisited unless there was an identified issue.

g) The failure of the CCO to ensure a standard process for orientation, training and competency evaluation was used at the facility resulted in nursing staff providing specialized services in which they were not competent to provide and potentially resulted in negative patient outcomes.
(Cross Reference A-0409)

Based on interviews and document reviews, the facility failed to ensure patient staffing assignments were made based on patient's needs and the competence of nursing staff for 13 of 14 personnel records reviewed (Employees #1, #2, #4, #6, #7, #9, #10, #11, #13, #14, #15, #16 and #23).

This failure resulted in patients receiving high alert intravenous (IV) and high risk IV vasoactive medications from staff who were not trained and evaluated for competence in the administration of the medications.

Findings:

POLICY

According to policy, Vasoactive Infusions, IV infusion of drugs for vasoactive effects must be administered and monitored by a nurse that has demonstrated competency at the facility.

According to the policy, Criteria for Medical Observation Unit, Examples of High Risk Med Infusions included (in part) Dopamine and Levophed. All nurses administering the above medications must have certification in advanced cardiac life support (ACLS) and have successfully completed the appropriate MOU (Medical Observation Unit) nursing competencies: i.e. telemetry, dopamine administration, including the RN Critical Care/High Observation unit competencies.

1. The facility failed to ensure nursing personnel were trained and had demonstrated competency before independently administering and monitoring patients on high alert and high risk IV medications in high observation areas.

a) During an interview, on 08/14/15 at 11:55 a.m., the Education Coordinator (Employee #20) clarified the term "High Observation" referred to a level of care where patients, or their medications, required more frequent monitoring than a Medical Surgical Unit could provide. This included patients who received hemodynamic and vasoactive IV medications or were receiving services in the Medical Observation Unit (MOU). S/he stated the facility's established "High Observation" competency process was not being followed and currently the High Observation competency was not required to be completed by any Registered Nurses (RNs) in the facility.

This was in contrast to the policy, Criteria for Medical Observation Unit, listed above.

b) Review of nursing staff training files for 13 of 14 RNs assigned to care for high observation patients in the MOU revealed they had not completed the RN Critical Care/High Observation Unit Competencies, despite having administered high alert and high risk IV medications.

There was no evidence RNs #1, #2, #4, #6, #7, #9, #10, #11, #13, #14, #15, #16 and #23 had been trained and deemed competent to provide care, including specialized services, to patients in the facility's MOU or high observation unit.

Record reviewed showed all 13 Registered Nurses who had not received a competency evaluation for the facility's High Observation Unit (MOU) provided care for patients in the MOU.

c) Additionally, facility RNs provided training and orientation for contracted agency staff to work in the MOU despite not having completed the required training and having his/her own skills evaluated to ensure services were provided in a safe and effective manner.

On 08/13/15 at 12:09 p.m., an interview with RN #2 revealed s/he had not received any training or guidance on how to train new nursing staff, despite having trained several new nurses, including contracted agency nurses. S/he stated RNs at the facility were asked to use their own nursing judgment when training nurses, and weren't offered any specific guidance as to what qualified new nursing staff as "competent."

RN #2 stated s/he trained a new contracted agency RN, and the focus of the training was on how to document, how to use the facility's computer charting software, how to contact physicians if needed, and how to look up which physician to call.

d) On 08/12/15 at 11:23 a.m., an interview with RN #1 revealed s/he had 1 year of rehabilitation nursing experience and was on his/her first assignment in an acute care setting. RN #1 stated she did not receive training or a competency evaluation for administration and maintenance of IV Heparin, IV Dopamine, or IV Epinephrine, nor had s/he administered those medications previously in another environment.

RN #1 stated s/he asked several times for a protocol sheet and never received one. S/he did not receive a sheet with heparin protocol while in training. RN #1 stated sometimes s/he didn't feel the support was adequate; s/he would ask for a policy on something and the facility would say they didn't have a policy.

i) Medical Record review revealed RN #1 administered and maintained a continuous IV Heparin infusion after assuming care of Patient #10 on 06/07/15, but failed to follow facility policy and protocols by not monitoring blood draws according to the Heparin Infusion Protocol.
The Heparin by Weight Order Set stated to obtain a Partial Thromboplastin Time (PTT) level 6 hours after IV Heparin initiation and every 6 hours until therapeutic range was achieved on two consecutive draws. IV Heparin was initiated by another RN during the shift prior to RN #1 assuming care of Patient #10 on 06/07/15.

After the IV Heparin was initiated on 06/06/15, PTT levels were not drawn every 6 hours until therapeutic range was achieved on two consecutive draws. RN #1 failed to collect any PTT draws during the course of his/her shift on 06/07/15, which contributed to PTT lab draws not being collected on Patient #10 from 06/07/15 at 5:05 a.m. until 6/8/15 at 6:04 a.m., approximately 25 hours later.

The patient's PTT values were unknown during this time, despite the patient continuously receiving an IV Heparin infusion. Further, no paper or computer documentation was available to confirm the rate of IV Heparin infusion during RN #1's shift on 06/07/15.

ii) Record review revealed RN #1 administered and maintained continuous infusions of high risk IV Dopamine after assuming care of Patient #18 on 06/03/15.

According to facility policy, Vasoactive Infusions, IV infusion of drugs for vasoactive effects must be administered and monitored by a nurse that had demonstrated competency at the facility.

Further, the record revealed the infusion rate for the IV Dopamine was changed by RN #1 on 06/03/15 at 3:00 p.m. However, vital signs were not monitored pursuant to facility protocol.

According to procedure, Vasoactive Infusions, patient vital signs were to be monitored every 15 minutes during the first hour at any change in dose. RN #1 collected and charted vital signs only every 30 minutes.

iii) On 08/12/2015 at 3:30 p.m., an interview with the facility's Education Coordinator (Employee #20) confirmed RN #1's training record did not contain any demonstrated competencies at the facility for high alert/high risk medications, nor did the record contain the required RN Critical Care/High Observation unit competency.

e) Record review revealed RN #23 provided services, for Patient #6, and administered IV Levophed in the facility's High Observation Unit with no evidence s/he had received specialized training and was deemed competent to administer the high risk medication.

i) Review of a Medication Administration note, dated 07/19/15 at 11:19 a.m., stated RN #23 initiated the IV Levophed (norepinephrine) drip. According to documentation the Levophed drip was to be titrated to keep the MAP >60 (mean arterial pressure).

According to the procedure, Vasoactive Infusions, the patient's vital signs were to be monitored every 15 minutes during the first hour of initiation and any change in dose. The procedure stated to document in the patient's permanent medical record reassessment or infusion change and the patient's response to the Vasoactive infusion and procedure.

There was no documentation the patient's vital signs were obtained until 07/19/15 at 12:01 p.m. (45 minutes after initiation), according to a Change of Condition note, at which time the patient's blood pressure (BP) was 93/52. There was no documentation RN #23 monitored the patient's vital signs every 15 minutes during the first hour of initiation. Additionally, there was no evidence RN #23 monitored the patient's MAP to assess the patient's response to the Vasoactive infusion.

ii) Review of a Change of Condition, dated 07/20/15 at 11:26 a.m., revealed RN #23 documented Patient #6's BP (blood pressure) was stable, the MAP was 80-100 and the Levophed was titrated down to 0.01 mcg/kg/min per the physician.

Patient #6's vital signs were recorded at 12:00 p.m. and 1:00 p.m. and not every 15 minutes as required after a change in dose in Vasoactive infusions pursuant to hospital policy.

iii) Review of a physician's telephone order, received by RN #23 on 07/20/15 at 3:42 p.m., showed an order to increase Patient #6's Levophed to 0.02 mcg/kg/min. There was no documentation in the medical record of the patient's status which resulted in the increase in dose. Additionally, there was no documentation to show RN #23 monitored the patients' vital signs and MAP prior to or subsequent to the increase in the Vasoactive infusion.

Specifically, Patient #6's BP was 118/76 at 1:00 p.m. on 07/20/15 and was not documented as reassessed until 07/20/15 at 7:00 p.m., 6 hours later. There was no documentation the patient's MAP was assessed during this entire time.

f) Record review revealed RN #14 provided services, for Patient #16, and administered Levophed in the facility's High Observation Unit with no evidence s/he had received specialized training and was deemed competent to administer the high risk medication.

i) Medical record review showed a physician's order, dated 07/13/15 at 5:09 p.m., to initiate a heparin IV infusion at a rate of 18 units per kilogram per hour (units/kg/hr).

A Stat PTT lab was ordered and collected on 07/13/15 at 5:40 p.m. to establish the patient's baseline levels. The result of the baseline PTT was 39 seconds. However, based off the baseline PTT (collected when the Heparin was first started) RN #14 requested an order which resulted in the patient receiving a heparin, 2500 unit, IV bolus and a rate increase to 20 units/kg/hr at 9:30 p.m.

According to the facility's protocol the next PTT was due on 07/14/15 at 11:40 p.m., 6 hours after the infusion was started. However, the PTT was not collected until 07/14/15 at 3:30 a.m., approximately 10 hours after initiation of the medication. There was no documentation as to why a PTT had not been obtained 6 hours after the high alert medication was begun as required by the facility's protocol.

The result of the PTT was 221.2 seconds, which was documented as a critically high level, according to the laboratory results section of the medical record. According to the Heparin Titration Flowsheet, the heparin infusion was discontinued at 6:50 a.m., 3 hours and 20 minutes after the critical PTT was drawn.

g) Additional record review showed similar deficient practice in which RNs #2, #4, #6, #7, #9, #10, #11, #13, #15, and #16 were assigned to care for patients in the facility's High Observation Unit with no evidence they had received specialized training and been deemed competent to provide the services. (Cross Reference A-0409)

Based on interviews and document reviews, the facility failed to ensure contracted personnel were properly oriented, their competencies were evaluated, and the contracted personnel adhered to the facility's policies and procedures for 2 of 2 non-employee (contracted) Registered Nurse (RN) personnel reviewed (RNs #1 and #23).

This failure resulted in patients not being appropriately monitored while receiving high alert intravenous (IV) and high risk IV vasoactive medications.

Findings:

POLICY

According to facility policy, Heparin Infusion Protocol, an aPTT (Partial Thromboplastin Time) should be drawn every 6 hours after Heparin infusion initiation until the therapeutic range is achieved on two consecutive draws.

According to facility policy, Vasoactive Infusions, IV infusion of drugs for vasoactive effects must be administered and monitored by a nurse that has demonstrated competency at the facility.

According to facility procedure, Vasoactive Infusions, patient vital signs are to be monitored every 15 minutes at any change in dose.

According to the policy, Criteria for Medical Observation Unit, Examples of High Risk Med Infusions included (in part) Dopamine and Levophed. All nurses administering the above medications must have certification in advanced cardiac life support (ACLS) and have successfully completed the appropriate MOU (Medical Observation Unit) nursing competencies: i.e. telemetry, dopamine administration, including the RN Critical Care/High Observation unit competencies.

1. The facility failed to ensure non-employee (contract) nursing personnel were trained and had demonstrated competency before independently administering and monitoring patients on high alert and high risk IV medications in high observation areas.

a) Record reviews revealed no competency evaluation was present in personnel and training files for 2 of 2 agency Registered Nurses (RNs) reviewed (RNs #1 and #23).

b) On 08/12/15 at 3:30 p.m., an interview with the Education Coordinator (Employee #20) confirmed the training files did not contain any competency testing or evaluation.

c) During an interview, on 08/14/15 at 11:55 a.m., the Education Coordinator (Employee #20) clarified the term "High Observation" referred to a level of care where patients, or their medications, required more frequent monitoring than a Medical Surgical Unit could provide. This included patients who received hemodynamic and vasoactive IV medications or were receiving services in the Medical Observation Unit (MOU). S/he stated the facility's established "High Observation" competency process was not being followed and currently the High Observation competency was not required to be completed by any Registered Nurses (RNs) in the facility.

This was in contrast to the policy, Criteria for Medical Observation Unit, listed above.

d) On 08/13/15 at 12:09 p.m., an interview with RN #2 revealed s/he had not received any training or guidance on how to train new nursing staff, despite having trained several new nurses, including contracted agency nurses. S/he stated RNs at the facility were asked to use their own nursing judgment when training nurses, and weren't offered any specific guidance as to what qualified new nursing staff as "competent."

RN #2 stated s/he trained a new contracted agency RN, and the focus of the training was on how to document, how to use the facility's computer charting software, how to contact physicians if needed, and how to look up which physician to call.

RN #2 stated s/he "assumed" non-employee (agency) nurses were already nurses, which meant s/he didn't need to teach them specific nursing skills. S/he stated s/he was under the impression the one day training, for agency nurses, was to orient them to the facility and not to assess their nursing skills.

RN #2 confirmed high alert/high risk medication administration and monitoring was not part of the one day, agency RN training s/he provided.

e) On 08/12/15 at 11:23 a.m., an interview with RN #1 (a non-employee agency nurse) revealed s/he had 1 year of rehabilitation nursing experience and was on his/her first assignment in an acute care setting. RN #1 stated s/he did not receive training or a competency evaluation for administration and maintenance of IV Heparin, IV Dopamine, or IV Epinephrine, nor had s/he administered those medications previously in another environment.

RN #1 stated s/he asked several times for a protocol sheet and never received one. S/he did not receive a sheet with heparin protocol while in training. RN #1 stated sometimes s/he didn't feel the support was adequate; s/he would ask for a policy on something and the facility would say they didn't have a policy.

i) Medical Record review revealed RN #1 administered and maintained a continuous IV Heparin infusion after assuming care of Patient #10 on 06/07/15, but failed to follow facility policy and protocols by not monitoring blood draws according to the Heparin Infusion Protocol.
The Heparin by Weight Order Set stated to obtain a PTT level 6 hours after IV Heparin initiation and every 6 hours until therapeutic range was achieved on two consecutive draws. IV Heparin was initiated by another RN during the shift prior to RN #1 assuming care of Patient #10 on 06/07/15.

After the IV Heparin was initiated on 06/06/15, PTT levels were not drawn every 6 hours until therapeutic range was achieved on two consecutive draws. RN #1 failed to collect any PTT draws during the course of his/her shift on 06/07/15, which contributed to PTT lab draws not being collected on Patient #10 from 06/07/15 at 5:05 a.m. until 6/8/15 at 6:04 a.m., approximately 25 hours later.

The patient's PTT values were unknown during this time, despite the patient continuously receiving an IV Heparin infusion. Further, no paper or computer documentation was available to confirm the rate of IV Heparin infusion during RN #1's shift on 06/07/15.

ii) Record review revealed RN #1 administered and maintained continuous infusions of high risk IV Dopamine after assuming care of Patient #18 on 06/03/15.

According to facility policy, Vasoactive Infusions, IV infusion of drugs for vasoactive effects must be administered and monitored by a nurse that had demonstrated competency at the facility.

Further, the record revealed the infusion rate for the IV Dopamine was changed by RN #1 on 06/03/15 at 3:00 p.m., however, vital signs were not monitored pursuant to facility protocol.

According to procedure, Vasoactive Infusions, patient vital signs were to be monitored every 15 minutes during the first hour at any change in dose. RN #1 collected and charted vital signs only every 30 minutes.

iii) On 08/12/2015 at 3:30 p.m., an interview with the facility's Education Coordinator (Employed #20) confirmed RN #1's training record did not contain any demonstrated competencies at the facility for high alert/high risk medications, nor did the record contain the required RN Critical Care/High Observation unit competency.

f) Record review revealed RN #23 (a contracted agency nurse) provided services, for Patient #6, and administered IV Levophed in the facility's High Observation Unit with no evidence s/he had received specialized training and was deemed competent to administer the high risk medication.

i) Review of a Medication Administration note, dated 07/19/15 at 11:19 a.m., stated RN #23 initiated the IV Levophed (norepinephrine) drip. According to documentation the Levophed drip was to be titrated to keep the MAP >60 (mean arterial pressure).

According to the procedure, Vasoactive Infusions, the patient's vital signs were to be monitored every 15 minutes during the first hour of initiation and any change in dose. The procedure stated to document in the patient's permanent medical record reassessment or infusion change and patient's response to Vasoactive infusion and procedure.

There was no documentation the patient's vital signs were obtained until 07/19/15 at 12:01 p.m. (45 minutes after initiation), according to a Change of Condition note, at which time the patient's blood pressure (BP) was 93/52. There was no documentation RN #23 monitored the patient's vital signs every 15 minutes during the first hour of initiation. Additionally, there was no evidence RN #23 monitored the patient's MAP to assess the patients response to the Vasoactive infusion.

ii) Review of a Change of Condition, dated 07/20/15 at 11:26 a.m., revealed RN #23 documented Patient #6's BP (blood pressure) was stable, the MAP was 80-100 and the Levophed was titrated down to 0.01 mcg/kg/min per the physician.

Patient #6's vital signs were recorded at 12:00 p.m. and 1:00 p.m. and not every 15 minutes as required after a change in dose in Vasoactive infusions pursuant to hospital policy.

iii) Review of a physician's telephone order, received by RN #23 on 07/20/15 at 3:42 p.m., showed an order to increase Patient #6's Levophed to 0.02 mcg/kg/min. There was no documentation in the medical record of the patient's status which resulted in the increase in dose. Additionally, there was no documentation to show RN #23 monitored the patients' vital signs and MAP prior to or subsequent to the increase in the Vasoactive infusion.

Specifically, Patient #6's BP was 118/76 at 1:00 p.m. on 07/20/15 and was not documented as reassessed until 07/20/15 at 7:00 p.m., 6 hours later. There was no documentation the patient's MAP was assessed during this entire time.

Based on interviews and document review, the facility failed to ensure nursing personnel received special training and were competent to administer intravenous (IV) medications in accordance with hospital policies, procedures and protocols in 4 out of 4 medical records reviewed for patients requiring high alert and high risk intravenous (IV) medications (Patients #6, #10, #16 and #18).

This failure resulted in inadequate patient monitoring and potentially contributed to negative patient outcomes.

Findings:

POLICY

According to Intravenous Heparin by Weight Order Set, facility staff were to obtain a PTT 6 hours after initiation and every 6 hours until therapeutic range is achieved on two consecutive draws. Then, obtain a PTT daily every morning and according to the sliding scale.

According to the procedure, Vasoactive Infusions, monitor vital signs every 15 minutes during the first hour of initiation and any change in dose.

According to the policy, Vasoactive Infusions, IV infusions for vasoactive effects must be administered and monitored by a nurse that has demonstrated competency at the facility. Refer to the Hospital Nursing Department competencies.

According to the policy, Criteria for Medical Observation Unit, Examples of High Risk Med Infusions included (in part) Dopamine and Levophed. All nurses administering the above medications must have certification in advanced cardiac life support (ACLS) and have successfully completed the appropriate MOU (Medical Observation Unit) nursing competencies: i.e. telemetry, dopamine administration, including the RN Critical Care/High Observation unit competencies.

According to the facility document, Denver In House Lab Testing Menu, Stat testing is 1 hour from the time of collection and all tests can be provided stat with the exception of the Sedrate and Microbiology assays.

1. The facility failed to ensure nursing staff were trained and completed a competency evaluation in the administration and monitoring for high alert IV medications.

a) Review of the medical record for Patient #10 showed s/he was admitted to the facility on 06/06/15 for ventilation wean.

i) Record review revealed a physician's order, dated 06/06/15 at 4:58 p.m., to initiate a heparin IV infusion and titrate to keep the Partial Thromboplastin Time (PTT) at 44-77.

According to the Nurses notes, dated 06/07/15 at 3:15 a.m., and completed by Registered Nurse (RN) #4, the heparin IV infusion was executed as ordered on 06/06/15 at 8:00 p.m. However, the Medication Administration note, dated 06/08/15 at 1:16 p.m., contained conflicting documentation that stated the Heparin infusion was started at 06/08/15 at 7:30 a.m. (more than 11 hours after the nurses' note) by RN #9.

Review of staff training records revealed neither RN #4 or RN #9 had received training and demonstrated competency on administration of high risk IV medications, including IV Heparin. RN #4 stated during an interview, on 08/11/15 at 8:17 a.m., s/he had never received training on the initiation and management of the medication, nor had s/he administered the medication previously in another environment.

ii) A baseline STAT Partial Thromboplastin Time (PTT) was ordered and collected on 06/06/15 at 8:15 p.m. According to the Lab Testing Menu, Stat testing turn-around time was 1 hour from the time of collection. The results of the PTT were not reported until 06/07/15 at 6:26 a.m., which meant the patient's PTT results were not known for more than 10 hours, despite the patient continuously receiving a heparin IV infusion during that time. The results of the PTT were 62.1 seconds which would indicate the next lab draw was due in 6 hours (06/07/15 at 2:15 a.m.).

A second PTT was documented as collected on 06/07/15 at 5:05 a.m., approximately 9 hours after the first PTT was collected. There was no documentation as to why a PTT had not been obtained 6 hours after initiation as required by the Intravenous Heparin by Weight Order Set, dated 06/06/15. The PTT result was 51.2 seconds which was therapeutic. According to the Intravenous Heparin by Weight Order Set, the next PTT was due to be collected on 06/07/15 at 11:05 a.m. as Patient #10 still had not had PTTs drawn every 6 hours until two consecutive therapeutic levels were achieved.

However, there was no documentation a subsequent PTT was collected until 6/8/15 at 6:04 a.m., approximately 25 hours after the second PTT was collected. There was no documentation to show why a PTT had not been obtained 6 hours after the previous lab draw was collected. The PTT was 68.8 seconds. According to the Order Set, the next PTT would be due in 6 hours as the patient had not achieved a therapeutic range on two consecutive lab draws that were drawn 6 hours apart.

The patient's next PTT was collected on 06/09/15 at 5:40 a.m., approximately 24 hours after the previous PTT was collected. The PTT was sub-therapeutic at 31.5 seconds, which resulted in a physician order, dated 06/09/15 at 9:23 a.m., for a heparin 5000 unit IV bolus, and a rate increase from 1100 units to 1500 units per hour, as instructed by the Intravenous Heparin by Weight Protocol.

The patient had a subsequent PTT drawn on 06/09/15 at 3:28 p.m. that was critically high at 128.5 seconds. According to the Order Set, a PTT greater than 91 warranted holding the heparin IV infusion for one hour, then decreasing the infusion by 3 units/kg/hr and rechecking the PTT in 6 hours. RN #10 only held the heparin IV infusion for 42 minutes, and then decreased the heparin infusion.

Review of RN #10's training record revealed s/he had not received training or completed a competency evaluation of the administration and monitoring of high risk IV medications.

A PTT was drawn 4 ½ hours after the heparin infusion was restarted on 06/09/15 at 11:15 p.m., which was 1 ½ hours before the next collection time was due.

iii) Additional record review revealed RN #1 administered a continuous IV Heparin infusion, after assuming care of Patient #10 on 06/07/15, but failed to follow facility policy and protocols by not monitoring blood draws according to the Heparin Infusion Protocol.
The Heparin by Weight Order Set stated to obtain a PTT level 6 hours after IV Heparin initiation and every 6 hours until therapeutic range was achieved on two consecutive draws. IV Heparin was initiated by another RN during the shift prior to RN #1 assuming care of Patient #10 on 06/07/15.

After the IV Heparin was initiated on 06/06/15, PTT levels were not drawn every 6 hours until therapeutic range was achieved on two consecutive draws. RN #1 failed to collect any PTT draws during the course of his/her shift on 06/07/15, which contributed to PTT lab draws not being collected on Patient #10 from 06/07/15 at 5:05 a.m. until 6/8/15 at 6:04 a.m., approximately 25 hours later.

Further, no paper or computer documentation was available to confirm the rate of IV Heparin infusion during RN #1's shift on 06/07/15.

On 08/12/15 at 11:23 a.m., an interview with RN #1 (a non-employee agency nurse) revealed s/he had 1 year of rehabilitation nursing experience and was on his/her first assignment in an acute care setting. RN #1 stated she did not receive training or a competency evaluation for administration and maintenance of IV Heparin, IV Dopamine, nor had s/he administered those medications previously in another environment.

RN #1 stated s/he asked several times for a protocol sheet and never received one. S/he did not receive a sheet with heparin protocol while in training. RN #1 stated sometimes s/he didn't feel the support was adequate; s/he would ask for a policy on something and the facility would say they didn't have a policy.

iv) A rapid response was called for Patient #10 on 06/10/15 at 7:19 p.m., related to the patient's respiratory rate, heart rate, acute mental status change, and acute decline in the patient's oxygen level. At 7:19 p.m. the patient's blood pressure (BP) was 78/40, heart rate (HR) 36, respiratory rate (RR) was 47 and O2 saturation was 88%.

According to the Primary Care Progress Note, on 6/10/15 at 9:45 p.m., Patient #10's proxy was informed the patient was likely bleeding internally and in order to determine the exact source, the patient would need to transfer to another hospital for advanced imaging. The patient's proxy changed Patient #10's status to DNR (do not resuscitate) and wished only for blood products to be administered.

Blood labs that were collected during the rapid response on 06/10/15 at 7:30 p.m. included a STAT Complete Blood Count (CBC) and PTT. According to the medical record, Laboratory Results, the PTT results were critically high at 133.8 seconds (orders were to maintain a range of 44-77), hemoglobin was 5.3 (normal range 14.3-18.1) and the hematocrit was 16.3 (normal range 39.2-50.2)

Subsequently, the patient expired on 06/11/15 at 3:53 a.m.

The staffing of Patient #10 by Registered Nurses who had not been trained and had their competencies evaluated in the administration of IV Heparin resulted in Patient #10 receiving a high alert medication without the patient being monitored pursuant to hospital policies and procedures for nearly the entire duration of his/her 4 days at the facility before s/he expired.

b) Review of the medical record for Patient #16 showed s/he was admitted to the facility on 07/13/15 for sepsis, multiple abdominal abscesses and renal failure.

i) Record review revealed a physician's order, dated 07/13/15 at 5:09 p.m., to initiate a heparin IV infusion at a rate of 18 units per kilogram per hour (units/kg/hr). Documentation on the Heparin Titration Flowsheet reported the Heparin IV infusion was initiated at a rate of 18.3 units/kg/hr on 07/13/15 at 5:35 p.m.

A Stat PTT lab was ordered and collected on 07/13/15 at 5:40 p.m. to establish the patient's baseline levels. The result of the baseline PTT was 39 seconds. However, based off the baseline PTT (collected when the Heparin was started), RN #14 requested an order which resulted in the patient receiving a heparin 2500 unit, IV bolus, and a rate increase to 20 units/kg/hr at 9:30 p.m.

Review of RN #14's training and personnel record showed s/he had not received training or completed a competency evaluation on the administration and monitoring of high risk IV medications.

According to the facility's protocol the next PTT was due on 07/14/15 at 11:40 p.m., 6 hours after the infusion was started. However, the PTT was not collected until 07/14/15 at 3:30 a.m., approximately 10 hours after initiation of the medication. There was no documentation as to why a PTT had not been obtained 6 hours after the high alert medication was begun as required by the facility's protocol.

The result of the PTT was 221.2 seconds, which was documented as a critical high level according to the laboratory results section of the medical record. According to the Heparin Titration Flowsheet, the heparin infusion was discontinued at 6:50 a.m., 3 hours and 20 minutes after the critical PTT was drawn.

The staffing of Patient #16 by Registered Nurses who had not been trained and had their competencies evaluated in the administration of heparin infusions, resulted in Patient #16 receiving a high alert medication without the patient being monitored pursuant to policies and resulted in a critically high PTT.


35823

2. The nursing staff failed to monitor high risk vasoactive IV medications pursuant to the facility's policies and procedures and to ensure staff caring for patients who received high risk vasoactive IV medications were qualified and deemed competent.

a) Review of the medical record for Patient #6 showed s/he was admitted to facility on 04/08/15 with acute respiratory failure.

i) Review of a Physician Orders, dated 07/19/15 at 10:57 a.m., showed an order for norepinephrine (Levophed) IV drip, start at 0.01 mcg/kg/min and titrate to keep MAP (mean arterial pressure) >60.

RN #23 (a contracted agency nurse) was assigned to care for Patient #6 from 7:00 a.m. to 7:00 p.m., on 07/19/15. Review of RN #23's training file revealed no evidence s/he had received training and demonstrated competency on the administration or maintenance of high alert medications.

According to the procedure, Vasoactive Infusions, the patient's vital signs were to be monitored every 15 minutes during the first hour of initiation and any change in dose. The procedure stated to document in the patient's permanent medical record, reassessment or infusion change and the patient's response to Vasoactive infusion and procedure.

Review of a Medication Administration note, dated 07/19/15 at 11:19 a.m., stated RN #23 initiated the IV Levophed (norepinephrine) drip. According to documentation the Levophed drip was to be titrated to keep the MAP >60.

There was no documentation the patient's vital signs were obtained until 07/19/15 at 12:01 p.m., according to a Change of Condition note, at which time the patient's blood pressure (BP) was 93/52. There was no documentation the facility monitored the patient's vital signs every 15 minutes during the first hour of initiation. Additionally, there was no evidence the facility monitored the patient's MAP to assess the patient's response to the Vasoactive infusion.

ii) Record review showed a Change of Condition, dated 07/20/15 at 12:34 a.m., where RN #6 documented Patient #6 had an episode of hypotension with a MAP of 61 at 11:00 p.m., on 07/19/15. RN #6 documented the patient was given 1000 ml bolus of fluids, 50 grams of albumin and the Levophed was increased to 0.05 mcg/kg/min, per physician's orders.

The patient's vital signs had last been checked on 07/19/15 at 6:05 p.m. (5 hours earlier). Additionally, there was no documentation to show the facility had been monitoring Patient #6's MAP prior to the hypotensive episode to assess the patient's response to the infusion.

Subsequent to the patient's hypotensive episode, which resulted in an increase in the patient's IV Levophed, there was no documentation the patient's vital signs were reassessed until 07/20/15 at 1:42 a.m., 2 hours and 42 minutes after the hypotensive episode. There was no evidence the RN monitored the patient's blood pressure every 15 minutes after the change in the Vasoactive infusion, pursuant to the facility's policy. Additionally, there was no documentation to show the RN was monitoring Patient #6's MAP to assess the effectiveness of the Levophed.

Review of RN #6's training file revealed no evidence s/he had received training and demonstrated competency on the administration or maintenance of high alert medications.

iii) Review of a Change of Condition, dated 07/20/15 at 11:26 a.m., revealed RN #23 documented Patient #6's BP was stable, the MAP was 80-100 and the Levophed was titrated down to 0.01 mcg/kg/min, per the physician.

Patient #6's vital signs were recorded at 12:00 p.m. and 1:00 p.m. and not every 15 minutes as required after a change in dose in Vasoactive infusions pursuant to hospital policy. Additionally, there was no documentation to show the patient's MAP was routinely monitored to assess the effectiveness of the medication.

iv) Review of a physician's telephone order, received by RN #23 on 07/20/15 at 3:42 p.m., showed an order to increase Patient #6's Levophed to 0.02 mcg/kg/min. There was no documentation in the medical record of the patient's status which resulted in the increase in dose. Additionally, there was no documentation to show the RN monitored the patient's vital signs and MAP prior to or subsequent to the increase in the Vasoactive infusion.

Specifically, Patient #6's BP was 118/76 at 1:00 p.m., on 07/20/15 and was not documented as reassessed until 07/20/15 at 7:00 p.m. There was no documentation the patient's MAP was assessed during this entire time.

Subsequently, a physician's telephone order was received, by RN #6 on 07/20/15 at 8:14 p.m., to decrease the Levophed dose to 0.01 mcg/kg/min and titrate to keep MAP above 60. There was no documentation the patient's BP was assessed until 07/20/15 at 10:53 p.m., over two hours after the change in rate of the Levophed. Further, there was no evidence Patient #6's MAP was monitored to assess the effectiveness of the Vasoactive infusion.

According to a physician's order, Patient #6's IV Levophed was discontinued on 07/23/15 at 10:12 a.m. There was no documentation of ongoing MAP monitoring for the entire time the patient was receiving the medication, a period of 4 days. It was not evident how the facility assessed the ongoing effectiveness of the medication.

v) During an interview, on 08/12/15 at 12:29 p.m., RN #7 stated s/he had taken care of Patient #6 while the patient was receiving IV Levophed, during an earlier episode. RN #7 stated s/he had never received training on the initiation and management of the medication. RN #7 stated s/he was not comfortable with the medication and had 3 other patients assigned to him/her while administer IV Levophed.

On 08/12/15 at approximately 4:00 p.m., all documentation of frequent monitoring for Patient #6, including vital signs and MAP monitoring was requested from the Chief Clinical Officer (CCO #19). The CCO provided additional copies of documentation already received by the surveyors. The CCO stated there was no additional documentation of vital sign monitoring and MAP monitoring for Patient #6.

The staffing of Patient #6 by Registered Nurses who had not been trained and had their competencies evaluated in the administration of Vasoactive infusions, resulted in Patient #6 receiving a high risk medication for approximately 4 days without the patient being monitored pursuant to hospital policies and procedures.

b) Review of the medical record for Patient #18 showed s/he was admitted to facility on 02/04/15 with acute respiratory failure.

i) Review of Physician Orders, dated 06/03/15 at 3:06 p.m., showed an order for dopamine IV infusion at 2.5 mcg/kg/min and titrate to keep heart rate above 50 beats per minute.

RN #1 (a contracted agency nurse) was assigned to care for Patient #18 from 7:00 a.m. to 7:00 p.m. on 06/03/15. Review of RN #1's training file revealed no evidence s/he had received training and demonstrated competency on the administration or maintenance of high alert medications.

According to the procedure, Vasoactive Infusions, the patient's vital signs were to be monitored every 15 minutes during the first hour of initiation and any change in dose. The procedure stated to document in the patient's permanent medical record reassessment of infusion change and the patient's response to Vasoactive infusion and procedure.

Review of the Frequent Vital Signs document for Patient #18 showed the dopamine IV infusion rate was changed to 2.5 mcg/kg/min and vital signs were assessed by RN #1 on 06/03/15 at 3:00 p.m. Vital signs were next documented at 3:30 p.m. and 4:00 p.m.

There was no documentation RN #1 assessed the patients vital signs every 15 minutes after the dose was changed.

ii) During an interview, on 08/12/15 at 11:23 a.m., RN #1 confirmed s/he had taken care of Patient #18 while s/he was receiving a dopamine infusion. RN #1 stated s/he did not recall any training for the administration or maintenance of dopamine. S/he stated sometimes s/he didn't feel the support of nursing staff was adequate.

On 08/12/2015 at 3:30 p.m., an interview with the facility's Education Coordinator confirmed RN #1's training record did not contain any demonstrated competencies at the facility for high alert/high risk medications.

The staffing of Patient #18 by a Registered Nurse who had not been trained and had their competencies evaluated in the administration of dopamine infusions resulted in Patient #18 receiving a high alert medication without the patient being monitored pursuant to hospital policies.